UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023273 |
|---|---|
| Receipt number | R000026822 |
| Scientific Title | Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty |
| Date of disclosure of the study information | 2016/07/22 |
| Last modified on | 2016/07/21 12:51:46 |
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Basic information
Public title
Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Acronym
Effects of group exercise on cognitive functions and amount of conversation: RCT in older people with social frailty
Scientific Title
Effects of group exercise on cognitive function and amount of conversation randomized control trial in older people with social frailty
Scientific Title:Acronym
Effects of group exercise on cognitive functions and amount of conversation: RCT in older people with social frailty
Region
| Japan |
Condition
Condition
Social frailty
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of group exercise on amount of conversation and cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1)Cognitive function
Word memory
2)Communication in daily living
Key secondary outcomes
1)Physical activity
2)Cognitive function
Executive function
Attention
Processing speed
3)Brain volume
4)Depressive symptoms
5)Physical function
Grip strength
Gait speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Perform group exercise for 90 min /a week for 44 times
Interventions/Control_2
Control group: self-conducted activity using self-monitoring note
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Satisfy the criteria of social frailty
2) Being able to exercise
3) 75 years or older
4) Being agreed with participation in the study
Key exclusion criteria
1) Have serious or unstable illness
2) Have disability
3) Have difficulty in exercise
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
Address
7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL
0562-44-5651
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Tsutsumimoto |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
Address
7-430, Morioka-cho, Obu city, Aichi, 474-8511, Japan
TEL
0562-44-5651
Homepage URL
k-tsutsu@ncgg.go.jp
Sponsor or person
Institute
Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japanese
Other related organizations
Co-sponsor
Obu city
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2016 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026822
